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OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
NCT04194398 · View on ClinicalTrials.gov ↗
Study Summary
Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.
Conditions Studied
Interventions
- DEVICE OCS Lung System
Study Locations (8)
California
- University of California at Los Angeles — Los Angeles
- University of California at San Francisco — San Francisco
Other
- Hospitals Leuven — Leuven
- Hannover Medical School — Hanover
Arizona
- St. Joseph's Hospital and Medical Center — Phoenix
Massachusetts
- Massachusetts General Hospital — Boston
Minnesota
- University of Minnesota — Minneapolis
North Carolina
- Duke University Medical Center — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2018-12-31 |
| Est. Completion | 2021-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04194398
The ClinicalTrials.gov registry entry for NCT04194398 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TransMedics, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with OCS Lung System appearing as the primary indexed condition, and to 1 intervention — of which OCS Lung System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04194398 reports 8 study locations spanning 6 distinct geographic areas — top geographies include California, Other, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04194398 about?
NCT04194398 is a clinical study titled "OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection". Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.
What is the current status of trial NCT04194398?
This trial is currently completed. The enrollment target is 79 participants. The study started on 2018-12-31. Estimated completion is 2021-09-30.
What conditions does trial NCT04194398 study?
This clinical trial studies the following conditions: OCS Lung System. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04194398?
The interventions under investigation include: OCS Lung System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04194398?
This trial is sponsored by TransMedics, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04194398 being conducted?
This trial has 8 study locations across Arizona, California, Massachusetts, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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